Eflapegrastim
As of the edition of 20 October 2026, Eflapegrastim is a protein: marketed, first approved in 2022 (US); acts on CSF3R; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Rolvedon
- First approved
- 9 September 2022 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Zydus Worldwide DMCC
- Registered trials
- 9, 0 stopped early
- Disease areas
- Cancer; Blood and lymph; Skin and connective tissue; Immune system
US protection
US protection ends in 2034.
US protection ends in 2034, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Zydus Worldwide DMCC. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Eflapegrastim.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CSF3R | Granulocyte colony-stimulating factor receptor | Q99062 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zydus Worldwide DMCC | Originator, Applicant and Lead sponsor of trials | 2013 to now |